Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score
研究概览
简要总结
Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.
详细描述
The current study seeks to determine whether transcatheter arterial embolization of abnormal neovasculature arising from the genicular arterial branches is safe and effective in the treatment of mild-to-moderate knee OA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-80 years of age of any gender;
- •Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit;
- •Knee pain resistant to conservative treatment for at least 3 months (anti- inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra- articular injection of hyaluronic acid and/or steroids);
- •Moderate to severe knee pain: pain VAS ≥ 40 mm with 0 representing 'no pain' and 100 'the worst pain imaginable. If both knees meet inclusion criteria, the one with a higher VAS score will be chosen for the study (i.e., target knee).
- •Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.
排除标准
- •Active systemic or local knee infection;
- •Active malignancy;
- •Life expectancy less than 12 months;
- •Prior ipsilateral knee surgery (within 3 years of baseline visit), arthroscopic surgery (within 6 months of baseline), total or partial knee replacement regardless of timing;
- •Ipsilateral knee intra-articular injection in the last 3 months;
- •Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus;
- •Pregnant during the study period;
- •Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure;
- •Body weight greater than 200 Kg;
- •Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure;
- •Known history of contrast allergy resulting in anaphylaxis;
- •Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain);
- •Post-traumatic knee (if trauma occurred within 12 months of baseline or was associated with fractures);
- •Known avascular necrosis in the target knee;
- •Contraindications to MRI such as such as claustrophobia, metallic fragment/implants, pacemaker.
结局指标
主要结局
Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score
时间窗: Baseline, Month 3
The WOMAC questionnaire includes 24 questions on daily activities. The Pain Score subsection includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question is scored on a Likert scale as follow: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater pain.
次要结局
- Change in WOMAC - Pain Score(Baseline, Month 12)
- Change in Visual Analogue Scale (VAS) Rating of Knee Pain(Baseline, Month 1)
- Change in VAS Rating of Knee Pain(Baseline, Month 12)
- Change in WOMAC - Stiffness Score(Baseline, Month 12)
- Change in WOMAC - Physical Function Score(Baseline, Month 12)
- Change in WOMAC - Overall Score(Baseline, Month 12)
- Change in Quality of Life Assessed Via 5-level EQ-5D Version (EQ-5D-5L)(Baseline, Month 1)
- Change in Quality of Life Assessed Via EQ-5D-5L(Baseline, Month 12)